ISO 9001 Benefits and Certification

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BSI
WELCOME
11/14/2014
Nuts and Bolts of ISO 9001
Jeff Witte, Vice President
Business Solutions BSI

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11/14/2014

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Quality Management - ISO 9001
11/14/2014

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What is ISO 9001?
• ISO 9001 is the world’s most established management system
framework.
• Currently, nearly a million organizations in 170 countries have
implemented, certified and more importantly recognized the
benefits of ISO 9001.
• It sets the standard not just for Quality Management Systems,
but management systems in general.
• ISO 9001 is helping all kinds of organizations to meet their
strategic objectives and succeed through improved customer
satisfaction and staff motivation.

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What is ISO 9001?
• A common sense, management system that focuses
on consistency, reliability, and improving the way an
organization operates
• Specifically, it focuses upon organizational
processes, the customer, and improvement
• ISO 9001 PROVIDES A FRAMEWORK FOR THE
ORGANIZATION TO OPERATE WITHIN NOT
HOW TO OPERATE.

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ISO 9000 family of standards
• ISO 9000:2005 – Quality Management Systems-
Fundamentals & Vocabulary
• ISO 9001:2008 - Quality Management Systems–
Requirements
• ISO 9004:2000 – Quality Management Systems- Guidelines
for Performance Improvement
.

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Who is ISO 9001 for?
11/14/2014

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Who is it for?
• Any organization in any sector who wishes to formalize the
way in which their organization operates
• Any organization who is looking to improve the way in
which it is managed.
• No organization is too large or too small to reap the
benefits of ISO 9001
• The best returns on investment come from companies
prepared to implement it throughout their organization
rather than particular sites, departments and divisions.

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Why introduce ISO 9001?
11/14/2014

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Why introduce ISO 9001?
• There needs to be a structure as to how an
organization operates.
• Customers are the most important stakeholder to an
organization.
• An organization needs to know and understand what
their customers’ needs are not only now but in the
future so that they can plan for the future to meet
customers’ needs.
• ISO 9001 will enable an organization to introduce a
structure through the use of processes and knowing
the needs of their customers.

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What does certification to ISO 9001 mean?
11/14/2014

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What does certification to ISO 9001 mean?
• Certification involves an independent third party such
as BSI assessing an implemented Quality Management
System
• The certification body will assess conformity to the
ISO 9001 standard
• This involves visiting the organization and assessing the
relevant systems and processes
• Maintaining certification will also involve periodic
reassessments

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Why do I need certification?
11/14/2014

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Why do I need certification?
• Demonstration to customers that the organization has a
commitment to quality
• Regular assessments ensure the organization continually
uses, monitors, and improves their processes
• Certification can improve business performance, reduce
uncertainty, and increase market opportunities
• Can increase profitability

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ISO 9001 and SMEs
• Can help you reduce your costs by removing inefficiencies and streamline your
processes
• It can also help to focus your limited resources on meeting your strategic and
customer objectives
• Give you peace of mind that you are managing the increasing legislative and
social demands on your business
• ISO 9001 only requires that you have six procedures, any other documentation
is up to you which can be electronic if you wish
• ISO 9001 is not about drowning in irrelevant manuals; keep it simple, a one
page flow chart can sometimes be enough
• A good starting point for any SME is to measure what it actually costs to run
the business
• Compares this to the cost when you have implemented it to measure your
return on investment (ROI)
• As a small or medium organization the question you need to ask yourselves is,
can you afford not to implement ISO 9001?

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ISO 9001: Evolution
1979
BS 5750:1979
ISO adopts BS 5750 as the basis for ISO standard
ISO 9001:1994 – Minor updates only
ISO 9001:1987
1987 1994
ISO 9001:2000 – Major update to introduce process approach
ISO 9001:2008 – Minor updates only
2000 2008 2015
ISO 9001:2015 – Major update

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What are the benefits to ISO 9001
11/14/2014

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Benefits of Certifying to ISO 9001
• Strategic
Having a management system that uses the ISO 9001 concepts means
that there can be the right controls in place to deal with the level of
risks to the organization
• Managerial
The management of the processes that ISO 9001 requires means that
management have a much clearer view as to how their organisation
operates
• Marketing
Having ISO 9001 registration enables an organization to show to their
current and future customers that they are committed to ensuring they
meet their requirements

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Benefits of Certifying to ISO 9001
•Financial
Provided an organization knows where it has started from re costs of
running the organization, it can show that savings can be made due to
increased efficiency and effectiveness of their management systems
•Operational
Having a management system in place will help all the people in the
organization to identify with their responsibilities and what their role is
in the organization. All people should be involved in the mapping of
their processes so that they own their part of the overall processes and
ultimately their contribution to the final product and service to the
customer
•Customer
The overriding concept behind the ISO 9000 series of standards is
meeting customers’ requirements. This is achieved by having a clear
understanding of the customers’ needs and having processes and
competent people to deliver the products/services

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What are the Drivers for ISO 9001?
11/14/2014

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Drivers for ISO 9001
• Provides international, expert consensus on state-of-the-art practices
for quality management
• Helps to provide a common language for dealing with customers and
suppliers worldwide in B2B
• Can improve efficiency and effectiveness
• Provides a model for continual improvement
• Provides a model for satisfying customers and other interested parties
• Can help to build quality into products and services from design
onwards.
• Helps to sustain business
• Helps with the qualification of suppliers for global supply chains
• Provides support for regulations

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Why Management Systems Are Important ?
People Processes Resources
Management system
CUSTOMER
REQUIREMENTS
BUSINESS
OBJECTIVES
STANDARD AND
REGULATORY
Customer satisfaction
The way you do things
Improved
performance
Improved staff
motivation
Inputs
Outputs

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Plan, Do, Check, Act
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The ISO 9001 Standard
The requirements of ISO 9001 do not tell
you “how” to run your business …
… THAT’S UP TO YOU
The requirements describe “what” needs
to be achieved

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Management System
Management
System
Customer
Satisfaction
Detailed
Strategic
Customer
Requirements
Detailed
Management
Plan
Plan
Resource
DoDo
Realize
Product /
Service
Act
Improve
Check
Measure
Analyze
Improve

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Model based on Plan, Do, Check, Act
•Plan – This is covered by the QMS, management responsibility, and
resource management
•Do – This is covered by “product realization” where following the
planning instructions are received from customers, and customer
services are provided
•Check – Before, during, and after the product realization process,
measurements are taken of the processes, the products and services
supplied, customer satisfaction, the management system through
internal audits, and any nonconformities raised
•Act - The improvement activities are continually improving the quality
system or change policies and processes to ensure that the
organization is kept in line with customer requirements and satisfaction.

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What Does a Properly Implemented System Look Like?
• Goals and objectives are set early
• Proper project management is in place
• Plans are developed and reviewed
• Reasonable timelines are established
• Progress is measured against time and money
• Implementation teams possess the right skills for the job
• The system is able to adapt and overcome

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What Does a Poorly Implemented System Look
Like?
• Not aligned with organizational objectives
• Built by one person or department
• Implementation occurred in less than four months
• Excessively documented

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Conformity Assessment
• Initial certification
audit
Stage 1
Stage 2
• Surveillance audit
• Recertification

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Nonconformity Definition
In ISO 17021, a nonconformity is defined as:
1. failure to fulfill one or more requirements of the management system
standard, or
2. a situation that raises significant doubt about the ability of the client's
management system to achieve its intended outputs
In ISO 9000, a nonconformity is defined as a:
1. Non-fulfillment of a requirement (3.6.2)

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Nonconformity – Minor
• Failure to comply with a requirement which (based on judgement and
experience) is not likely to result in management system failure
• Single observed lapse or isolated incident
• Minimal risk of nonconforming product or service
• Examples:
• A two month lapse in the audit program
• A training record not available

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Nonconformity – Major
• Absence or total breakdown of a system to meet a requirement
• A number of minors related to the same clause or requirement
• A nonconformity that experience and judgment indicate will likely result in
management system failure or significantly reduce its ability to assure
controlled processes and products

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Nonconformity – Major
Examples:
• No documented procedure for a required process/activity
• Document changes routinely made without authorization
• No awareness program for the management system
• No future planned internal audits
• Insufficient scope
• Numerous minor nonconformities found

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Opportunity for Improvement
•Any finding not classified as a nonconformance
•Any negative finding of a potential nonconformity will be classified as
an OFI
•There may be OFIs that are not potential nonconformities.

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ISO 9001 - Minor Nonconformities
32%
20%
20%
16%
12%
Top 5 Minor non-conformitiesby clause
7.6
4.2.4
5.6
4.2.3
6.3
Total Minor nonconformities:18,082
Sample data: Jan 1, 2009 – June 30, 2009

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ISO 9001 - Clause 7.6
• Control of monitoring and measuring equipment
• The organization shall determine the monitoring and measurement to be
undertaken and the monitoring and measuring equipment needed to provide
evidence of conformity of product to determine requirements
• The organization shall establish processes to ensure that monitoring and
measurements can be carried out and are carried out in a manner that is
consistent with monitoring and measurement requirements

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ISO 9001 – Clause 4.2.3 and 4.2.4
• Control of documents
• Documents required by the quality management system shall be controlled…
• A documented procedure shall be established to define the controls needed
• Approve documents for adequacy prior to issue
• Review and update as necessary and re-approve documents

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ISO 9001 – Clause 4.2.3 and 4.2.4
• A documented procedure shall be established to define the controls needed
• Ensure that changes and the current revision status of documents are
identified
• Relevant versions of applicable documents are available at point of use
• Documents remain legible and readily identifiable
• Documents of external origin determined by the organization to be
necessary for the planning and operation of the quality management
system are identified and their distribution controlled
• To prevent the unintended use of obsolete documents and to apply suitable
identification to them if they are retained for any purpose

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ISO 9001 – Clause 4.2.3 and 4.2.4
• Records established to provide evidence of conformity to requirements and of
the effective operation of the quality management system shall be controlled
• The organization shall establish a documented procedure to define the controls
needed for the identification, storage, protection, retrieval, retention, and
disposal of records
• Records shall remain legible, readily identifiable and retrievable

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ISO 9001 – Clause 5.6
• Management Review
• Top management shall review the organization’s quality management system,
at planned intervals, to ensure its continuing suitability, adequacy, and
effectiveness.
• This review shall include assessing opportunities for improvement and the
need for changes to the quality management system, including the quality
policy and quality objectives

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• Infrastructure
• The organization shall determine, provide and maintain the infrastructure
needed to achieve conformity to product requirements, infrastructure
includes, as applicable
• Buildings, workspace and associated utilities
• Process equipment (both hardware and software), and
• Supporting service (such as transport, communications or information
systems)

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ISO 9001 – Major nonconformities by clause

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8.2.2 Internal Audit
Conduct internal audits at planned intervals to determine if QMS:
• Conforms to:
 Planned arrangements (see 7.1)
 ISO 9001 requirements
 Organization requirements
• Is effectively implemented
• Is maintained

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• Plan the audit program taking into consideration:
• Status and importance of processes and areas
• Results of previous audits
• Define audit criteria, scope, frequency, and methods
• Select auditors and conduct audits to ensure:
• Objectivity
• Impartiality
• Ensure auditors do not audit their own work

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•Prepare a documented procedure to address responsibilities and
requirements for:
• Planning audits and conducting audits
• Recording results and maintaining records
•Ensure actions taken without undue delay
(management responsible for audited area)
•Verify actions taken and report the results
(also refer to clause 8.5.2)
Note: Reference ISO 19011:2002 for guidance

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8.5.2 Corrective Action
•Take action to eliminate cause of
nonconformities to prevent their recurrence
•Take action appropriate to the effects of problem
•Define requirements in documented
procedure to:
• Review nonconformities (including complaints)
• Determine the causes of nonconformities
• Evaluate need for actions to prevent recurrence
• Determine and implement corrective action
• Record results and review action taken

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• General Requirements
• The organization shall establish, document, implement and maintain a quality
management system and continually improve its effectiveness in accordance
with the requirements of this international standard
• Determine the processes
• Determine the sequence and interaction of these processes
• Determine criteria and methods needed to ensure that both operation and
monitoring of these processesavailability of resources and information
• Monitor, measure where applicable, and analyse these processes
• Implement actions necessary to achieve planned results

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Impact on the P & L
11/14/2014

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Common misconceptions
1.ISO 9001 delivers little value
2.ISO 9001 costs a lot to implement

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Period Expenses
Implementation
• Training
• Labor related to
implementation
Post Registration
• Ongoing costs
for registration
X<1% revenues
$3K/year to $500K/yr

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Increased Quality =
Reduced Cost of Quality
• 64% saw a reduction in the defect rate after
ISO 9000 registration
• 56% saw reduction in the cost of quality
(scrap, reworks, inspection, etc.)
ISO 9000 Survey (1999, McGraw-Hill)

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Increased Quality =
Reduced Cost of Quality
Company 1
Defects for a product:
•74,964 PPM before registration
•3,850 after registration
Company 2
Right first time batch production:
•Increased from c.85% - c.100% after registration
Company 3
Customer complaints:
•At one site, 6,000,000 units supplied, not one customer
complaint

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Proven Benefits
*2011 BSI review of stock prices over a 10 year period, comparing ISO 9001 certified companies with a benchmark index.
**2011 ASQ research. BSI Benefit Survey 2011 † BSI Customer Satisfaction Survey

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How Does Performance of Companies with ISO 9001
Compare to Those Without?
• ISO adopters had far lower organizational death rates than
matched firms within their industries.
• Sales and employment grew substantially more rapidly post
certification at ISO 9001 adopting firms than at matched firms.
• Total payroll and (to a lesser extent) annual earnings per
employee grew substantially more rapidly post certification at
ISO 9001 adopting firms than at matched firms.
• ISO 9001 adopters already had slightly lower than average
injury costs at the time of adoption
• Non adopters are 7 times as likely to go out of business than
ISO 9001 adopters
Levine, David I., and Michael W. Toffel. Quality Management and Job Quality: How the ISO 9001 Standard for Quality
Management Systems Affects Employees and Employers. Working Paper no. 09-018. Boston: Harvard Business School, 2010.
Print.

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ISO 9001:2015 Revision
11/14/2014

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Main changes
11/14/2014
• Use of the High Level Structure (HLS)
• More compatible with services
• Fewer prescriptive requirements
• Changes to key terms and definitions
• Organizational context must be understood
• ‘Relevant interested parties’ now added
• Scope now a requirement in its own right, dealing with requirements that
may not be applicable.
• No requirement for a ‘Quality Manual’

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Main changes cont.
11/14/2014
• Enhanced leadership requirements
• Policy and objectives are in line with the strategic direction of the
organization
• Management system to be within the organization’s existing processes
• Customer Focus now requires TM to ensure risks and opportunities that
can affect products and services are addressed
• No requirement for a management representative, but TM responsible for
ensuring roles, responsibilities and authorities and assigned for the MS
• Risk has been introduced to replace preventive action
• Process now require objectives where relevant
• Objectives expanded to include: who, what, when, etc.
• Planning of changes requirement new

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Strategic changes to date
•Enhanced emphasis on risk-based thinking
•Increased emphasis on achieving value for the organization and its
customers
•Increase flexibility on the creation and use of documentation
11/14/2014

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Main changes cont.
11/14/2014
• Risk:
effect of uncertainty on an expected result
• Note 1: An effect is a deviation from the expected – positive or negative
• Note 2: Uncertainty is the state, even partial, of efficiency of information
related to, understanding or knowledge of, an event, its consequence, or
likelihood
• Note 3: Risk is often characterized by reference to potential events (ISO
Guide 73, 3.5.1.3) and consequences (ISO Guide 73, 3.6.1.3), or a
combination of these
• Note 4: Risk is often expressed in terms of a combination of the
consequences of an event (including changes in circumstances) and the
associated likelihood (ISO Guide 73, 3.6.1.1) of occurrence

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Main changes cont.
11/14/2014
• Monitoring and measurement resources (Calibration)
• Explicit reference to organizational knowledge management
• Awareness requirement new
• Internal and external communications now a requirement
• Documented Information. No mandatory requirements, it’s up to you!
Enhanced requirements
• Design and development are now more general and may include service
design
• Outsourcing is now included in external provision (aka purchasing)
• Release of products and services now part of operational controls
• Non-conforming processes, outputs, and product and services.

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Main changes cont.
11/14/2014
• New structure and requirements for monitoring and measurement
• Internal audit to take into account quality objectives, customer feedback
and changes to the system when planning audits
• Management review to take into consideration:
• strategic direction of the organization
• external and internal issues
• effectiveness of action re risk and opportunities
• Improvement and continual improvement:
• Improving processes to prevent nonconformities
• Improving products and services to meet known and predicted
requirements
• Nonconformity and corrective action
• Recur and occur
• Nonconforming goods and services vs nonconformity

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Steps to Certification
11/14/2014

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Steps to certification
Make contact
Work with assessment team
Consider relevant training
Assessment & review
Certification and beyond

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11/14/2014
BSI Group America Inc.
Jeff Witte – jeffrey.witte@bsigroup.com
Main Office
Telephone: 888-429-6178 - USA
Email: Inquiry.msamericas@bsigroup.com
Links: http://www.bsiamerica.com

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